We seek to incorporate a Quality Engineer for a vacancy in the Quality Management Department of B.Braun Surgical, S.A. from Monday to Friday.Functions :
Leads or supports quality standards for the production line (components and processes) and suggests modifications meant to prevent defects in final product.Works closely with cross-functional teams, including product design, product management and operations, to identify and mitigate quality risks.Leads quality initiatives and continuous improvement activities.Audits production processes, raw materials or suppliers / vendors to ensure that established quality standards are met.Supports Supplier Quality in monitoring supplier performance.Leads or supports root cause analysis for defects, non-conformities or other quality failures.Reviews and approves product / process specification and procedures, as well as deviations documentation.Develops Quality and Sampling Plans as needed.Supports product and process validation activities.Acquires and analyzes data using appropriate quantitative methods to facilitate process analysis and improvements.Supports organization in terms of Statistics and process controls.Uses problem solving techniques to conduct complaint investigation, root cause analysis, CAPA, and quality improvement when necessary.Ensures compliance of the assigned processes with formal external quality standards applicable to Manufacturing of Medical DevicesOther duties may be assignedRequirements :
BS in Engineering preferred.4+ years Quality Engineering experience with a Medical Device Company required.Must have understanding of ISO13485, FDA QSRs and ISO14971.Proficient in the use of Microsoft Excel, Power Point and Word.Use of Minitab and other statistical tools.Requires good written and interpersonal communication skills in English.Process experience in sterilization processes preferred.Knowledge of statistics and process controls preferred.Six Sigma and Lean methodology training / experience preferred.Position located Rubi. Must be able to travel.Works well in a team environment with limited supervision.Analytical Skills and Pays attention to detail is required.If you believe your experience and professional interests are align with the offer, I encourage you to apply!J-18808-Ljbffr
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